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‘Disgraced’ manufacturer fined for lying about thyroid drug shelf-life
19 Mar 2024
News
An ex-director may avoid jail time after a manufacturer submitted “falsified” shelf-life data to the medicines watchdog, the MHRA has revealed.
Medicines manufacturer Kappin Ltd and its “disgraced” former director Kamlesh Vaghjiani were last week (March 15) sentenced for “two charges of falsifying data” on a medicine’s shelf life, “adversely affecting its quality…to obtain a licence to sell the medicine in the UK”, the watchdog announced.
The criminal prosecution and sentence, as well as the termination of marketing authorisations in 2013, came after the Medicines and Healthcare products Regulatory Agency (MHRA) “brought the deceptions to light”, it said.
The MHRA said on Friday that it “began to investigate Kappin Ltd in 2008 following reports” that its hypothyroidism medicine Evotrox Oral Solutions “was not stable for the whole duration of the shelf-life claimed in the original licence application”.
chemistanddruggist.co.uk/CD...
The official government press release is here:
Press release
Disgraced company director convicted of falsifying medicine quality data
A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality in order to obtain a licence to sell the medicine in the UK.
Today’s sentencing concludes the UK’s first successful prosecution of a manufacturer for knowingly providing falsified data to the MHRA in order to obtain a Marketing Authorisation.
Kamlesh Vaghjiani, former director of pharmaceutical company Kappin Ltd, was sentenced to eight and seven months on two counts, to run concurrently, both suspended for 18 months, at Southwark Crown Court, London following investigations by the Medicines and Healthcare products Regulatory Agency (MHRA) into Kappin’s product, Evotrox Oral Solution.
Vaghjiani and Kappin Ltd were both individually fined £50,000, having previously paid a confiscation order of £1,075,589.88, reflecting Kappin Limited’s profit from the crime. Kappin Ltd was also ordered to pay prosecution costs of £82,262.20.
Evotrox Oral Solutions (a liquid solution containing the active ingredient levothyroxine) was licensed in 2006 in three strengths for the treatment of hypothyroidism (underactive thyroid).
As part of any licence application, manufacturers must provide evidence for how long their product remains stable and hence fit for purpose, effective and safe. This is known as a medicine’s ‘shelf-life.’
The MHRA began to investigate Kappin Ltd in 2008, following reports that Evotrox was not stable for the whole duration of the shelf-life claimed in the original licence application. At this time, Kamlesh Vaghjiani was the Quality Assurance Manager at Kappin Ltd.
During these enquiries, the company continued to submit falsified data to the MHRA to try to support the medicine’s stability and effectiveness. A comprehensive series of independent testing by the MHRA, together with detailed analysis of data retrieved from laboratory computers brought the deceptions to light. This culminated in the termination of the marketing authorisations by the MHRA in 2013 and subsequent criminal prosecution which resulted in today’s sentence.
Andy Morling, MHRA Deputy Director (Criminal Enforcement), said:
This is a shocking case of a pharmaceutical company that thought it was above the law and was not required to uphold our stringent standards for safety, quality and effectiveness.
The lengths to which they were prepared to go to cover up their wrongdoing are completely unacceptable.
Whilst the MHRA found no evidence that patients were harmed, the fact that the manufacturers were prepared to put them at risk by knowingly supplying a substandard product is very concerning.
This was an extremely complex investigation that required the analysis and challenge of thousands of scientific data files. I am pleased that we have brought those responsible to justice and the severity with which the courts have treated the case should serve as a warning to all medicines manufacturers.
In October 2023, Kamlesh Vaghjiani and the company, Kappin Ltd, changed their pleas to guilty for all charges.
Other levothyroxine products currently available on the market are not affected.
gov.uk/government/news/disg...
Unveiling the legal ramifications of falsified medicine quality data: A case analysis
solicitorsjournal.com/sjart...
Scottish recall notice:
29 August 2012
Dear Healthcare Professional,
DRUG ALERT CLASS 2 NO 27 – IMMEDIATE
D R U G A L E R T
CLASS 2 MEDICINES RECALL
publications.scot.nhs.uk/fi...
Maybe some members actual received Evotrox? I remember it was around for a while then suddenly disappeared.
The DM+D has this information:
Listed from 30-08-2006
Pack size information
Pack size and UOM 100 ml
Discontinued
Discontinued Date 29-09-2011
dmd-browser.nhsbsa.nhs.uk/a...
I had actually been under the impression that it had disappeared because the product had been mis-formulated. That is, I thought they had used 100 micrograms of levothyroxine pentahydrate rather than levothyroxine anhydrous. The effect of that being to make it sub-potent by the water (hydration) - a few micrograms down - about 12 micrograms in 100 micrograms. (All chemical calculations must be based on the anhydrous form to make them comparable.)
I was very wrong.
